Frequently Asked Questions

We are located in sunny South Florida, but we have partnered with organizations all over the world to provide highly-quality uniquely annotated clinically-collected and remnant human biospecimens. View our global site network footprint.

Our central laboratory is CAP-accredited and CLIA-certified, and our biobank holds ISO 13485:2016 certification.

A donor who is negative for HIV, HCV, HBV, and Syphilis with no reported symptomology is considered healthy. However, a donor may still be considered healthy but have pre-existing medical conditions such as diabetes or other conditions. We offer healthy patient biospecimens and relevant clinical data to support your research studies. Explore our biospecimen inventory.

Our team can collect almost any human biospecimen from our global prospective site network. We collect a variety of specimens that can be obtained to your exact research specifications with inclusion and exclusion criteria designed in partnership with Boca Bio to meet your unique research needs.

We can also get you access to remnant samples. The data from these samples is limited to test results, the assays and instruments used, and basic donor demographics. Explore our biospecimens, and if you don’t see what you need, please contact one of our many experts — we are ready to help.

Boca Bio’s team are experts at logistics. Whether it's international or domestic, we have years of experience handling biospecimens for our core biospecimens business, and you can benefit from our expertise. We handle all of the import/export, paperwork, and customs to deliver high-quality annotated samples directly to your location, so you don't have to worry.

Remnants are derived from standard-of-care testing, usually offering limited volume, data, and test results. Clinically collected samples are procured to the client’s specifications, giving you more both in volume and the depth of clinical data.

Typically, we collect treatment status, symptoms, risk history for the particular indication, comorbidities, vaccination history, and more.

As part of our ISO 13485:2016 quality management system, we follow SOPs that de-identifies subjects with a unique donor code (e.g. D00001234). Each specimen has its own unique sample code (e.g. S00001234) to identify samples from multiple or longitudinal draws from the same subject.

Boca Bio commits to maintaining the highest data standards with our industry-leading Laboratory Information Management System (LIMS). Our biorepository is ISO 13485:2016 accredited. From collection through analysis and storage, we ensure best-in-class data handling with our on-site data team.

Boca Bio offers a complement of clinical research services, including site and collection management, data capture, and coordination to ensure your pre-clinical and discovery studies run seamlessly to achieve desired milestones. We offer end-to-end services, so you don’t have to manage the details.

Yes, Boca Bio maintains compliance with all IRB approvals in place for our U.S. sites, as well as ethics committee/MOH approval for all international sites.

One of the advantages of using Boca Bio is that we have established IRB/ethics committee/MOH approvals in place for your projects. Some IRB/ethics committee/MOH approval processes can take weeks or months depending on the site and location. If a protocol approval is not in place, then an application will be submitted to the IRB/ethics committee/MOH.

We have a global footprint of 120+ collection sites worldwide, in over 60 countries.

Yes, we can provide monitoring services for your research study. We conduct a site initiation visit, interim monitoring visits, and a project close-out visit.

Yes. From initial concept to market approval or study closure, our team ensures comprehensive project and site management throughout every phase of your project.

Our site and project management approach combines meticulous planning, continuous monitoring, and effective communication, ensuring projects stay on track and within budget.

Our team maintains weekly communication with our sites and updates clients on progress and delivery expectations on an ongoing basis.

Based on your specific inclusion and exclusion criteria, we will assess the feasibility of your study design and consult with your team before providing a formal quote to ensure you have accurate information to make decisions that impact your study.

Yes, we have an in-house CLIA-certified and CAP-accredited reference laboratory for any additional sample characterization or validation testing needed.

Boca Bio’s central laboratory conducts various types of method comparison and reference studies to support clients in the clinical and diagnostic industries. Here is a list of some typical studies and reference services offered:

The laboratory employs several state-of-the-art technology platforms:

Boca Bio's central laboratory is CLIA-certified and CAP-accredited, ensuring adherence to high standards of quality and compliance in laboratory testing​​​​.

The central laboratory offers a comprehensive test menu that includes advanced chemistry and molecular testing for diagnostic validation and biomarker analysis, with the flexibility to accommodate specialized testing requests to meet client project requirements​​.

Yes, Boca Bio prides itself on our flexibility, responsiveness, and ability to work with our clients to deliver customized testing solutions to meet unique client requirements now and as technologies emerge.

Our lab maintains the highest quality standards that meet or exceed the requirements for CAP-accreditation and CLIA-certification. Our team implements rigorous quality control measures and a LIMs system to ensure our data and test results are reliable and accurate. This commitment to quality is a core aspect of all of our service offerings​​.

Clients work with a dedicated project manager who ensures that all study aspects are conducted according to the client's specifications. This single point of contact maintains clear and consistent communication, manages the project timeline, and resolves any challenges that may arise during the study​​.

We offer a broad spectrum of central lab services, with a large test menu including but not limited to biomarker analysis, infectious disease testing, and women's health testing, all performed in our on-site CLIA-certified and CAP-accredited lab.

We offer an array of specialized assays and instruments, including method comparison studies, precision studies, and validation studies, each designed to support the development and optimization of diagnostic tests and methodologies. Our comprehensive services ensure the reliability, accuracy, and clinical relevance of your research and diagnostic tools, from early development through market approval.

Boca Bio provides ISO 13485:2016 certified, full BSL-1, and BSL-2 biostorage facilities, which include options for long-term and short-term cryostorage. They maintain temperatures ranging from ambient, -80°C to -20°C, as well as liquid nitrogen storage options for various types of biological specimens​​.

Our ISO 13485:2016 certified biostorage facility is equipped with real-time, scalable monitoring systems that keep track of inventories, storage conditions, and data management through a Laboratory Information Management System (LIMS). This ensures that all samples are securely monitored and maintained​​.

Yes, Boca Bio is planning to launch a client-facing portal that will allow customers to manage their sample orders and inventories directly, enhancing accessibility and ease of management​​.

The integration of Boca Bio’s biostorage services with our extensive testing services makes us a unique trusted partner. This coupling offers convenience, efficiency, and speed, as clients can store and test their samples in one seamless process, reducing logistical complexities and improving turnaround times​​.

Yes, our facility is purpose-built to accommodate a wide range of biological materials, including but not limited to, human tissue, blood samples, DNA/RNA samples, and other biofluids that require regulated environments​​.

The biostorage services are compliant with all relevant regulatory standards, ensuring that they meet the necessary requirements for human sample storage. This includes adherence to ISO 13485:2016 guidelines to ensure the highest level of quality and safety​​.

You should contact your assigned sales representative and/or dedicated project manager for any inquiries.

You should reach out to your assigned sales representative or dedicated project manager immediately for assistance.

Send your PO to [email protected].

Timeframes vary based on the specific study requirements and necessary approvals. The expected wait time will be communicated in your study protocol or statement of work.

Yes, we can design a custom collection kit to fit your study requirements. Sponsors can also provide us with proprietary collection kits if needed.